FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: RESPONDING TO FDA FORM 483 OBSERVATIONS AT THE CONCLUSION OF A DRUG CGMP INSPECTION: DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, March 9 -- Food and Drug Administration has issued a notice called: Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on March 9 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection." This guidance is intended for foreign and domestic human and animal drug manufacturing establishments inspected by FDA whose drugs are regulated by the Center for Dr...